NCT01104779

Safety and Efficacy of Cariprazine in Schizophrenia

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Cariprazine	Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
DRUG	Placebo	Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Timeline

• Start date: 2010-04-27
• Primary completion: 2011-12-15
• Completion: 2011-12-15
• First posted: 2010-04-15
• Last updated: 2018-11-14
• Results posted: 2018-11-14

Locations

41 sites across 4 countries: United States, Colombia, India, South Africa